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CompletedNCT00849446Updated Aug 24, 2011

Validity and Reliability of an Activity Monitor in Persons With a Cerebrovascular Accident

An observational study in Cerebrovascular Accident, sponsored by University College of Antwerp. Completed at 1 site in Belgium. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-08-24.

Sponsored by University College of Antwerp · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
30
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Background:Accelerometry has only recently been introduced in clinical stroke research. However, whether accelerometry is a valid and reliable tool in stroke needs to be established. From literature becomes clear that existing accelerometers show shortages at patients with stroke because of the specific deficits that these patients have.

Purpose: The aim of this study is to investigate the validity and test-retest reliability of the SenseWear Pro armband as an objective measurement of physical activity in chronic stroke patients.

Patients and Methods Subjects: Fifteen patients and fifteen healthy subjects will be included in the study following written informed consent. The following demographic and clinical data were recorded: age, gender, height, length, medication use, self-reported handedness, Edinburgh Handedness Inventory, Rivermead Gross Function, Functional Ambulation Categories, medical and surgical history.

Methods: During one test session the subjects had to carry out an amount of activities according to a standardised protocol existing of lying down, sitting, standing, walking, step exercise and cycling. These activities are presenting activities of daily living.

Measures:Subjects wear on both arms a SenseWear Pro Armband. De data from these measuring devices will be compared with the data retrieved from 2 Yamax pedometers and the ergospirometry device. The outcome measures are: counts, heartbeat, oxygen used, energy expenditure, METabolic equivalent, time lying down.

Read the detailed description

Evaluation of the SenseWear Pro Armband to assess physical activity in individuals with chronic stroke

Background:

Accelerometry has only recently been introduced in clinical stroke research. However, whether accelerometry is a valid and reliable tool in stroke needs to be established. From literature becomes clear that existing accelerometers show shortages at patients with stroke because of the specific deficits that these patients have.

Purpose:

The aim of this study is to investigate the validity and test-retest reliability of the SenseWear Pro armband as an objective measurement of physical activity in chronic stroke patients.

Patients and Methods Subjects Fifteen patients and fifteen healthy subjects will be included in the study following written informed consent. The following demographic and clinical data were recorded: age, gender, height, length, medication use, self-reported handedness, Edinburgh Handedness Inventory, Rivermead Gross Function, Functional Ambulation Categories, medical and surgical history.

Methods During one test session the subjects had to carry out an amount of activities according to a standardised protocol existing of lying down, sitting, standing, walking, step exercise and cycling. These activities are presenting activities of daily living.

Measures:

Subjects wear on both arms a SenseWear Pro Armband. De data from these measuring devices will be compared with the data retrieved from 2 Yamax pedometers and the ergospirometry device. The outcome measures are: counts, heartbeat, oxygen used, energy expenditure, METabolic equivalent, time lying down.

02

Conditions studied

  • Cerebrovascular Accident

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03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 30 is below the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University College of Antwerp is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Fifteen patients and fifteen healthy subjects will be included in the study following written informed consent. The following demographic and clinical data were recorded: age, gender, height, length, medication use, self-reported handedness, Edinburgh Handedness Inventory, Rivermead Gross Function, Functional Ambulation Categories, medical and surgical history.

Inclusion criteria

  • an ischemic or hemorrhagic stroke
  • stroke onset less than 3 months
  • score 3 or more Functional Ambulation Categories
  • age \< 80 years
  • ability to cycle independently
  • written authorisation on the informed consent

Exclusion criteria

Exclusion criteria:

  • serious other diseases which might have an influence on carrying out the standardised activities
  • cannot understand and carry out simple instructions
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
30 participants (estimated)

Groups and cohorts

  • Activity monitoring in CVA patients

    Device: Activity monitor (SenseWear Pro armband)

  • Activity monitoring in healthy persons

    Device: Activity monitor (SenseWear Pro armband)

Interventions

  • DeviceActivity monitor (SenseWear Pro armband)

    Activity monitoring during specific physical activities such as walking at different speeds

    Also known as: Sensewear

06

What researchers measure

Primary outcomes

  1. Total energy expenditure (kcal)during selected physical activities

    Time frame: measurement at 1 time point

Secondary outcomes

  1. Number of steps

    Time frame: measurement at 1 time point

07

Study locations

1 site
  • University Hospital of Antwerp
    Edegem, Antwerp 2650, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00849446
Lead sponsor
University College of Antwerp
Collaborators
Universiteit Antwerpen
Responsible party
Sponsor
First posted
Feb 23, 2009
Start date
Feb 2009
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Aug 24, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.

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